Published: 11 April 2024
Consultations
Outcome of the consultation on standards for contraceptive devices in New Zealand
Summary
About the consultation
Submissions received
Outcome
Implementation
Enquiries
Summary
- Medsafe sought comments on updating the gazetted standards applicable to four groups of contraceptive devices.
- Medsafe received 11 responses to the consultation.
- Download the consultation outcome document to view the consultation
feedback:
Standards for contraceptive devices in New Zealand – Consultation outcome (PDF, xx KB, 9 pages) - Medsafe will recommend that the updated standards be gazetted.
- These standards will take effect from the date of the gazette notice, and contraceptive devices supplied in New Zealand from that date will be required to meet the new standard.
About the consultation
Contraceptive devices supplied in New Zealand, as required under section 6 of the Contraception, Sterilisation and Abortion Act 1977, must comply with standards as published in the New Zealand Gazette by the Minister of Health.
The last change to the gazetted standards for these devices was in 2014. Since that time, four of the five ISO standards gazetted at that time have been updated, one of the NZ standards that was gazetted has been removed by Standards New Zealand. This consultation proposed replacing some older standards with the latest versions of these standards – as shown in Table 1.
Table 1: Contraceptive device standards under consultation
| Standard to be replaced | Standard name | New standard |
|---|---|---|
| ISO 4074:2002e / Corrigenda 1:2003 | Natural Latex Rubber Condoms, Requirements and test methods | ISO 4074:2015 |
| ISO 25841:2011 | Female Condoms – Requirements and test methods | ISO 25841:2017 |
| ISO 8009:2004 | Mechanical contraceptives – Reusable natural and silicone rubber contraceptive diaphragms, requirements and tests | ISO 8009:2014 |
| ISO 7439:2011 | Copper-bearing contraceptive intrauterine devices – Requirements and tests | ISO 7439:2015 |
The New Zealand Standard, NZS 7102:1980 Specifications for Intra-Uterine Contraceptive Devices, was withdrawn by Standards New Zealand in 2014. The consultation feedback identified that no contraceptive devices are currently being supplied that meet this withdrawn standard.
The consultation opened on 17 March 2020 and closed on 14 May 2020.
Submissions received
There were 11 responses to the consultation. Respondents included importers, health care professionals, members of the public, manufacturers, sponsors (suppliers), industry organisations and a community health organisation.
Medsafe would like to thank all those who took the time to respond to the consultation and provide comments.
To view a summary of the submissions, please download the Consultation outcome document.
- Standards for contraceptive devices in New Zealand – Consultation outcome (PDF, 233 KB, 9 pages)
Outcome
After consideration of the consultation feedback, Medsafe has decided that the updated standards should be recommended for gazettal.
Medsafe will arrange for the four new standards to be gazetted.
Implementation
The new standards will be effective from the date of the gazette notice. Any new product imported or introduced to the market must comply with the new standard.
Enquiries
For any enquiries about this consultation, please email devices@health.govt.nz and put Contraceptive Standards in the subject line of your email.
